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Marek EHRLICH MD
Director Aneurysm Program
Dept. Cardiac Surgery
Univ. of Vienna
Austria
1HOUSTON 2017
Larry Fortensky
2HOUSTON 2017
Spectrum Total Arch
Conventional Debranching Total EndovascularFET
3HOUSTON 2017
HistoryHistory: Single: Single BBranchedranched DDeviceevice
• Based on Relay NBS (Non-Bare Stent)• Based on Relay NBS (Non-Bare Stent)
Plus platform
• Internal tunnel and window – bridging• Internal tunnel and window – bridging
graft to be deployed under ostium of
target vessel
• Intended for Zone 0 deployment
combined with preceded double
debranching
HOUSTON 2017
Second anterior tunnel for LCA
HOUSTON 2017
Arch Graft System (Bolton) is a Custom Made Device Arch Graft System (Bolton) is a Custom Made Devicea nd only re com m e nde d force rta inpa tie nts
Im pla nta tion is now re se rve d for ca re fully se le cte d Im pla nta tion is now re se rve d for ca re fully se le cte dce nte rs worldwide with long te rm e xpe rie nce inTEVA Rtre a tm e nttre a tm e nt
A im is toim ple m e nta com m e rcia lly a va ila ble “A rch Ste ntde vice ”de vice ”
HOUSTON 2017
Individual Graft Design – Overview
DE
A BF
C
A = 32-48m mA = 32-48m mB = 22-48m m (50m m forcustom )C = 255 m m (for45m m D )
270 m m (for60m m D )C ustom m inim um le ngth
D = 45 or60m mE = 50mm ONLY FIXED DISTANCE
F = 26m m ifA :32-34m mC ustom m inim um le ngth150 (forD a t45m m )160 (forD a t60m m )
F = 26m m ifA :32-34m mF: 32m m ifA :36-42m mF: 38m m ifA :44-48m m
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
Graft Design – Tunnel Length and Diameter
G
D
G
H
G :Poste riortunne l forB C TH :A nte riortunne l forL C A
H
Tunnel LengthTunnel Length
LengthD
LengthG
LengthH
60 m m 40 mm 35 mm
45 m m 35 mm 30 mm
C O N FID EN TIA L –B oltonM e dica l inte rna l use only
8
HOUSTON 2017
Bridging Stents Design
B /D :70-80-90-100-120-140 m m
C /E:8-9-10-11-12-13-14-16-18-20-22-24 m m
B D
C /E:8-9-10-11-12-13-14-16-18-20-22-24 m m
C E
C O N FID EN TIA L –B oltonM e dica l inte rna l use only
E
HOUSTON 2017
RelayBranch Design: Lock-Stent
• Tunnels feature Lock-Stent technology that prevents branch disjunction• Tunnels feature Lock-Stent technology that prevents branch disjunction
Lock-StentLock-Stent
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
Goal - Device of the Shelf
D E
A BF
C
A :proxim a l e nd (9 siz e s)B :dista l e nd (14 siz e s)C :tota l cove re d le ngth(2 siz e s)
D :frontportion(2 options)E:fe ne stra tion’s le ngth(fixe d)F:fe ne stra tion’s width(fixe d)
Aim - Catalogue of 25 – 30 modules
C :tota l cove re d le ngth(2 siz e s) F:fe ne stra tion’s width(fixe d)
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
# Code Center Country Investigators1 392 O spe da le G .B rotz u -C a glia ri Ita ly dr.S.C a m pa rini
2 811 O sa k a U nive rsity H ospita l Ja pa n dr.T.Kura ta ni
3 331 H opita l R a ngue il -Toulouse Fra nce prof.H .R ousse a u
4 391 O spe da le Sa nC a m illo-R om a Ita ly prof.P.G .C a o
5 333 H opita l G e orge Pom pidou -Pa ris Fra nce dr.J.M .A lsa c
6 441 St.M a ry's H ospita l -L ondon U nite d Kingdom dr.M .H a m a dy
7 461 L ink ö ping U nive rsity H ospita l -L ink ö ping Swe de n dr.C .Forsse ll
8 341 H ospita l U C A de O vie do Spa in dr.M .A lonso
9 311 U tre chtU nive rsity H ospita l -U tre cht N e the rla ndsprof.F.M oll,dr.J.Va nH e rwa a rde n
10 491 M a inz H ospita l G e rm a ny dr.E.W e iga ng
11 492 U nive rsitätk linik um Fre iburg -Fre iburg G e rm a ny dr.B .R ylsk i
12 493 U nive rsitätsk linik um G ie ß e n G e rm a ny dr.A .Koshtov
13 495 U nive rsitätsk linik W ie n A ustria dr.Funovics,Ehrlich13 495 U nive rsitätsk linik W ie n A ustria dr.Funovics,Ehrlich
HOUSTON 2017
Patient Clinical Requirements
Patient treated with the branched devices have to meet the following
conditions:conditions:
• suitable for positioning the guidewire and the tip of the main device into
the Left Ventricle (no mechanical aortic valve)
• suitable for maneuvers to manage the blood pressure with rapid pacing
• subject must have :
• aortic inner diameter of 43 mm or less and a healthy proximal neck
length of 30mm
• 60mm as minimum required distance between sinotubular junction• 60mm as minimum required distance between sinotubular junction
and innominate artery
• femoro-iliac axes compatible with the profile of the system (24 Fr)
C O N FID EN TIA L –B oltonM e dica l inte rna l use only
• femoro-iliac axes compatible with the profile of the system (24 Fr)
HOUSTON 2017
Aortic diameters of reference
ZERO point 50m m
1:a ortic dia m e te r a t 45m m or60m m (whe n a pplica ble )from60m m (whe n a pplica ble )fromthe Z e roPoint
2: a ortic dia m e te r a t the Z e roPoint
5** to10 m m
23
5
4
Point
3: a ortic dia m e te r 50m m fromthe Z e roPoint
4:a ortic dia m e te r 130m m from
15 4:a ortic dia m e te r 130m m from
the Z e roPoint
5:a ortic dia m e te r 210m m fromthe Z e roPoint
6the Z e roPoint
6: a ortic dia m e te r a t dista lla nding z one (EXTR A G R A FT)
Aortic diameters of reference
7
87:B C T dia m e te rrightbe fore thebifurca tion
9ZERO point
9’8 bifurca tion
8:B C T dia m e te r1cm a bove theosthium
9: L C A dia m e te r in a stra ight9: L C A dia m e te r in a stra ighta re a a t le a st 3cm a bove theostium
9’: L C A dia m e te r in a nothe r9’: L C A dia m e te r in a nothe rloca tion of it to confirm them e a sure m e nt
HOUSTON 2017
ACCESS SITES
• Left or Right Femoral access for main
device (1or 2) and angio catheter
• RCA access for branch graft (3)
• LCA access for branch graft (4)
• Brachial access (right) for angiographic
catheter (5) or as needed to inject in
innominate bifurcationinnominate bifurcation
• Venous access for pacing leads
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
TU N N EL G R A FTPL A C EM EN TPL A C EM EN T
M A R KER S
Proxim a l m a rk e rs gra ft
M a rk e rofbe ginning ofpock e t
M a rk e rofe nd ofpock e t
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
MAIN BODY GRAFT PLACEMENT
Advance secondary sheath to
proximal landing zoneproximal landing zone
Position the graft to align the tunnel
pocket with the ostium of the BCTpocket with the ostium of the BCT
and LCA artery. Align the tunnel
marker 5-10 mm proximal to the
BCT (0 point)
Deploy the tunnel graft under rapid
pacing
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
BRANCH GRAFT FOR BCT and LCA ARTERYCANNULATION OF BOTH TUNNELSCANNULATION OF BOTH TUNNELS
Turn C-arm between LAOTurn C-arm between LAO
and RAO to visualize
anterior and posterior
tunnelstunnels
Cannulate the posterior
and anterior tunnel usingand anterior tunnel using
a guide wire
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
Am I inside and which tunnel ?
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
The important thing is to be able to recognize
the tunnelsthe tunnels
PO STER IO R TU N N EL(B C T)
A N TER IO R TU N N EL(L C A )(B C T) (L C A )
• It’s approximately 5mm longer than theanterior
• It’s approximately 5mm shorter than theanterioranterior
• It runs “on the left” ofthe middle marker ofthe fenestration
anterior
• It runs “on the right”of the middle markerof the fenestrationthe fenestration of the fenestration
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
Is Cannulation ok? Which tunnel?
Two ways to check thatthe wire is in the tunnel:the wire is in the tunnel:
-Angiogram
-PTA Balloon-PTA Balloon
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
3 pa tie nts ,m e a na ge 74 a
Indications:Indications:
a) Penetrating ulcer in the aortic arch after st. p. IMH in
ascending aorta – AA graft replacementascending aorta – AA graft replacement
b) Penetrating Ulcer in the aortic arch
c) St. p. Type B with TEVAR, 1a Endoleak – 7 cm arch aneurysmc) St. p. Type B with TEVAR, 1a Endoleak – 7 cm arch aneurysm
2 patients needed subclavian - left carotid bypass before the2 patients needed subclavian - left carotid bypass before the
procedure
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
Comorbidites:Comorbidites:
Patient 1:St.p.IM H a nd A sce nding R e pla ce m e nt,st.p.la rynge a l
ca nce rwithne ck disse ctiona nd ra dia tion,st.p.Strok e 2008,
C O PD G old III
Patient 2:St.p.A A A withEVA R A ptus,C O PD III.st.p.prosta te
ca nce r,st.p.strok e 2010,st.p.colonca nce r2000,St.p.fe m .pop
bypa ss,St.p.bulle k tom y a nd ple ure ce tom y le ftlung
Patient 3: St.p.type B disse ctionwithTEVA R ,st.p.tonguePatient 3: St.p.type B disse ctionwithTEVA R ,st.p.tongue
ca nce rwithne ck disse ctiona nd ra dia tion1996,G old II
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
Clinical Data ViennaClinical Data Vienna ––PostinterventionalPostinterventionalPostinterventionalPostinterventional
Mortality 0 %, Neurological Compl. –
ICU Stay – mean 4.6 days, 3-10 days
1 PRIND (Pt. 2) - Remission after 4th day
ICU Stay – mean 4.6 days, 3-10 days
2 pts – 6 months follow up – no Endoleak
1 pt – done last week – no prim. Endoleak
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
C O N FID EN TIA L –B oltonM e dica l inte rna l use onlyHOUSTON 2017
The B olton”A rchD e vice ”offe rs inthis firststa ge custom m a deThe B olton”A rchD e vice ”offe rs inthis firststa ge custom m a depe riod a via ble optionforse le cte d pa tie nts
Pre lim ina ry re sults look prom ising withPre lim ina ry re sults look prom ising withlow m orta lity a nd m orbidity ra te s
Itcould be com e a ne ffe ctive a nd sa fe ofthe she lftool forItcould be com e a ne ffe ctive a nd sa fe ofthe she lftool forpa tie nts witha ortic a rchpa thologie s
M ore shorta nd m id-te rm da ta is ne e de d toconfirm the be ne fitM ore shorta nd m id-te rm da ta is ne e de d toconfirm the be ne fitofthis de vice
HOUSTON 2017